510(k) Report

Devices descending from K050404

229 later devices reach Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+1K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+1K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+1K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+1K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080—
+1K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20062244
+1K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+2K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+2K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+2K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+2K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+2K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+2K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+2K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+2K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+2K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+2K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+2K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+2K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+2K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+2K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+2K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+2K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+2K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+2K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+2K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+2K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+2K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+2K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+2K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+2K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+2K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+2K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+2K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+2K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+2K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+2K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+2K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+3K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+3K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+3K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+3K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+3K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+3K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+3K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+3K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+3K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+3K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+3K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+3K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+3K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+3K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+3K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+3K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+3K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+3K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+3K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+3K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+3K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+3K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+3K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+3K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+3K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+3K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+3K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+3K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+3K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+3K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+3K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+3K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+3K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+3K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+3K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+3K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+3K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+3K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+4K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+4K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+4K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+4K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+4K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+4K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+4K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+4K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+4K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+4K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+4K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+4K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+4K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+4K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+4K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+4K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+4K181517Senhance Surgical SystemTransenterix, Inc.201810—
+4K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+4K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+4K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+4K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+4K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701